BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C
FDA Recall #Z-2284-2024 — Class II — May 15, 2024
Product Description
BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C
Reason for Recall
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
Recalling Firm
American Contract Systems Inc — Tiffin, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
552 units
Distribution
US Nationwide distribution.
Code Information
UDI-DI: 00191072200518 LOT#"s: 639231 928241
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.